According to a Georgetown University study last year, food-borne illnesses in the US cost $152 billion a year in lost productivity, medical bills and other expenses, not counting food industry costs when a product is recalled. The Food Safety Modernization Act (FSMA), signed into law by President Barack Obama on Jan. 4, established a framework for working toward eliminating such devastating costs for the industry.

The legislation directs the US Food and Drug Administration (FDA), working with a number of public and private partners, to build a new system of food safety oversight. FSMA focuses on preventing food safety problems, including pathogens and other dangers that may make people ill. Before this can happen, Congress and FDA must find funding to implement the new law. But it’s worthwhile for food processors to start planning now.

Richard Stier is a consulting food scientist with international experience in food safety including Hazard Analysis and Critical Control Point (HACCP) programs, food plant sanitation, quality systems, process optimization, good manufacturing practice (GMP) compliance and food microbiology. Certified as a seafood HACCP instructor with the Association of Food & Drug Officials (AFDO) and by the HACCP Alliance, he has worked with a wide range of processing systems and products, including canning, freezing, dehydration, deep-fat frying, aseptic systems and meat processing. He is also a food safety, GMP and quality systems auditor. Baking & Snack asked our contributing editor about his views on the implications of the act.

Baking & Snack: How will the Food Safety Modernization Act (FSMA) passed late last year change the relationship between food plants and federal regulators?

Richard Stier: I can’t envision that the Food Safety Modernization Act will change the current relationships with food processors too much. Of course, we will not know how enforcement will actually take place until the Food and Drug Administration (FDA) writes the appropriate regulations to enforce the act. Remember, acts of Congress are the law of the land, but they require regulations to be developed by the administering agency. The four biggest potential issues will be the ability of FDA to 1) conduct more inspections and access to records, 2) force mandatory recalls 3) [detain] food based on a “reason to believe” the food is adulterated or misbranded and 4) suspend registration. The last three issues substantially increase the power of FDA.

For the baking and snack industry, government access to records is minimal at the moment. With HACCP becoming mandatory for all processors regulated by FDA, HACCP plans, prerequisite programs and supporting documentation will now be made available to investigators. However, processors really should not be overly concerned about this. Why? Food safety has been driven by economic issues. Most bakeries, snack food producers and suppliers to those industries already have

HACCP plans and the prerequisite programs essential for ensuring the production of safe foods. The third-party audits mandated by purchasers — whether [processors] are required to develop and implement one of the audit schemes mandated through the Global Food Safety Initiative (GFSI) or another audit — include all the technical requirements described in the act. The bottom line is, processors and ingredient suppliers have had to develop these programs to maintain their customer base. No HACCP program. No business. Even the act’s article that addresses internal audits to evaluate the potential for intentionally introduced hazards such as bioterrorism should not create too many problems as most of the third-party audits include a food defense section.

How quickly can the law be enacted so that bakers and snack producers are affected and consumers see meaningful changes at their operations?

I can’t see the act having any major impacts on the way most processors are currently doing business. There will be more frequent inspections, which will take time and create angst amongst the management team, but if the company is currently meeting the requirements of third-party

audits, it should be able to handle anything that FDA throws at it. The baking and snack industry, and the products that its members manufacture, has not been a significant source for foodborne illness. There have been a few issues — such as salmonella in cereal, salmonella in potato chips that was sourced to the seasonings and others — but the industry has generally had a good safety record.

I also don’t envision that the appropriate regulations to enforce the act will be finalized for at least 1½ years and probably even longer — more like three years. The agency needs to draft the regulations and submit them for comment. In addition, it will also have to prepare guidance documents and white papers that address the new programs. Given the nature of the regulations and their potential impact, my guess is that one of the first things that will be seen is a request to “extend the commentary period.” So the bottom line is that we are probably looking at least two years before the regulations are finalized. In addition, I suspect that there may be a staggered implementation in that final regulation. The Mega-Reg for the meat and poultry industry had a 3-year implementation, allowing smaller operations more time to comply.

In the latest budget discussions, Congress and the Obama administration recommend cuts in FDA funding. What are you hearing about the impact of such cuts on the enhancement of plant inspections under FSMA?

FDA recently asked for $4.2 billion to enforce FSMA. It will be interesting to see how this plays out since there is a push to reduce spending. The [Obama] administration’s proposed budget of $3.7 trillion will probably be chopped significantly. One of the biggest issues with the act itself is that Congress passed a law yet did not allocate any money to enforce it. Rather a cart-before-the-horse kind of thing, isn’t it?

Can local public health authorities step into the breach? Should they? Will they?

I would hope that local health authorities are not encouraged to step in to fill the breach. Mentioning that there is a breach implies that there are significant issues that need to be addressed. Personally, I do not believe there are significant problems. In addition, given that local health authorities, state and city, often have their own ideas about consumer safety, asking them to step in might be a bad idea. Look at California and Proposition 65. That is something that should really go away as it is selectively enforced and really accomplishes nothing except adding cost to what consumers buy.

What is the one most important action that a responsible food plant operator can take to protect the safety of food products manufactured in his or her facility? Why?

The best thing that responsible food processors can do is to step back and take a long look at what they are doing and determine whether the procedures that they are using in their food quality, safety and sanitation programs are really effective. Subject these activities to a risk assessment and look for ways to do things better and more efficiently. This self-assessment, or internal audit, must also examine whether the operation is actually doing what has been documented. In addition, food processors need to determine whether their food safety management systems are working as a complete process. And if all procedures and work instructions are not properly documented or documented inaccurately, you know you have a problem. Third-party audits are supposed to do this, but audits are really a snapshot of an operation. So the internal audit should be very critical and aimed at finding gaps in the systems and filling them.

What are the most common breaches of food safety that you have seen in bakeries or snack plants?

I would guess that the most common food safety issue that I have seen in bakeries and snack plants involves mishandling of allergens. Most of the ingredients that are used in these industries are fairly safe such as grains, flour and sugar. However, how allergens are handled needs to be watched. Areas where flour, milk powders and other allergens are mixed and blended need to be well ventilated, and care must be taken to ensure workers don’t spread the allergen through the plant. But simple things like forgetting to turn on the blowers can create issues. This really gets down to good manufacturing and proper sanitation practices. When one takes a close look at outbreaks of food-borne illness, issues related to sanitation can almost always be found.

These breakdowns in sanitation often go back to training and education or a lack thereof. It is imperative that all processors make a commitment to training their workers and managers on all procedures and work instructions and that the training be documented as being effective. It is one thing to have someone sit for an hour and listen and another to ensure that he or she actually comprehended what was said.

Bakers have long relied on their ovens to solve (or prevent) microbial problems in finished foods. Why is this just a myth?

Well, we don’t know whether it is a myth or not. The assumption has always been, “It was baked or cooked, so it is safe.” The salmonella outbreaks from breakfast cereals were an eye-opener for the industry. I am seeing a trend in the baking industry toward validating current processes. Are these cakes, pies or cookies actually receiving enough heat to kill microorganisms of public health significance? The validation work will answer the question as to whether this is a myth or not. This will entail a great deal of work for the industry, however. Large operations have the resources — people and instrumentation — to do this, but what of the smaller operations? And what the large companies do will remain their proprietary data. What the Almond Board of California did following the outbreaks attributed to unprocessed almonds could be used as a model as to how an industry could address this issue. Perhaps the American Bakers Association or another organization can fund the research necessary to determine methods, target organisms, surrogate organisms and the other issues essential for validating a process.

Finally, what advice do you give bakers going forward?

I would encourage bakers to take a long look at what you are doing and seek to do better. Consider bringing in someone from the outside to help with the risk assessment, if you are not confident that you have the expertise in-house. There are always better ways to do things — look for them. Operations that are complacent and accept the status quo are usually the ones that start to falter. Seek to improve in all areas, and be critical of what you are doing at the moment.

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